MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD 2000 SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Catalog Number A2000

Device Problem Unintended Movement (3026)

Patient Problem Injury (2348)

Event Date 01/21/2019

Event Type  Injury  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

An operating room coordinator reported that the scalp injury occurred during a prone cervical spine case from the head moving inside the frame of the a2000 mayfield 2000 skull clamp on (b)(6) 2019.The patient's head was positioned pre-operatively in the prone position.Surgeon stated the clamp was at 80 pounds (lbs.) of pressure when positioning was complete.Physician felt the patient's head move during the case.Surgeon noted that all pressure on the mayfield hand screw was released at this point.The patient sustained a 2 to 3 inch scalp injury on the side of the frame with the two (2) pins.Injury was only at one pin site.Staples were used to close the wound.Additional information has been requested.

Event Description

N/a.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation.A device history record review could not be performed at this time as the lot number for a2000 provided (b)(4) is not in integra's quality system records.The failure mode could not be confirmed.A failure analysis and determination of root cause was not possible due to the lack of information received to perform a complete investigation.

• Brand Name: MAYFIELD 2000 SKULL CLAMP
• Type of Device: SKULL CLAMPS AND HEADREST SYSTEMS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 8345644
• MDR Text Key: 136492563
• Report Number: 3004608878-2019-00030
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K932807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A2000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1